Eversense CGM SENSOR — Class II medical device recall Z-0251-2020
Terminated recall by Senseonics, Inc., reported 2019-11-06, distributed nationwide. Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sen
| Recall number | Z-0251-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Senseonics, Inc., Germantown, MD, United States |
| Recall initiated | 2019-09-18 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-07-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,344 sensors |
| Serial numbers | 101037, 101050, 101057, 101076, 101095, 101116, 101118, 101121, 101140, 101155, 101170, 101171, 101175, 101189, 101190, 101194, 101204, 101232, 101244, 101245, 102618, 102622, 102634, 102650, 102658 and 475 more |
Product
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Reason for recall
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0251-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.